ClearanceBrief
Panels › Radiology › Product code LNH · Class 2

System, Nuclear Magnetic Resonance Imaging

Regulation 892.1000

28510(k)s in 12 months (1,110 all time)
60recalls in 12 months (723 all time)
630recalls that name a 510(k)
Get daily alerts for LNHSample briefCSV

Top companies in LNH

DateFirm and productCodeLinked 510(k)
Feb 2, 2012Siemens Medical Solutions USA, Inc
Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system.
Terminated
LNHK101347
Nov 28, 2011Philips Medical Systems (Cleveland) Inc
Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is
Terminated
LNHK110151
Oct 26, 2011GE Healthcare, LLC
GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000. The MSK Extreme TM MR Scanner is intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of th
Terminated
LNHK080048
Sep 1, 2011GE Healthcare, LLC
GE Healthcare, Discovery MR450 Product Usage: The Discovery MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam
Terminated
LNHK083147
Sep 1, 2011GE Healthcare, LLC
GE Healthcare, 3.0T Signa MR750 (Marketing Name: GE Discovery MR750) Product Usage: The GE Sigma MR750 System is a whole body magnetic resonance scanner designed to support high resolution and high
Terminated
LNHK081028
Sep 1, 2011GE Healthcare, LLC
GE Healthcare, 1.5T Optima MR450w Product Usage: The Optima MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam
Terminated
LNHK091536
Aug 10, 2011Siemens Medical Solutions USA, Inc
MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging
Terminated
LNHK101347
Jul 11, 2011Siemens Medical Solutions USA, Inc
Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System Nuclear magnetic resonance imaging system
Terminated
LNHK993731
Apr 18, 2011Siemens Medical Solutions USA, Inc
MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging.
Terminated
LNHK013586
K032428 +2
Mar 1, 2011Philips Medical Systems North America Co. Phillips
The Panorama HFO system has the Traceable Item Identification (12NC): 9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upgraded to R 2.5.3 via FCO). 9896 030 19641-SW R 2.5.3 9896 030 19861-SW R 2.6.1 9
Terminated
LNHK041602
Feb 24, 2011GE Healthcare, LLC
10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K103330) The Brivo MR355/ Optima MR360 is a whole body magnetic resonance scanner designed to support high res
Terminated
LNHK103330
Feb 24, 2011GE Healthcare, LLC
9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology) Signa Infinity MR System with EXCITE (K013636 Signa Infinity MR System with EXCITE Technology) The
Terminated
LNHK013636
Feb 24, 2011GE Healthcare, LLC
8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Signa 3.0T with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) The GE S
Terminated
LNHK030874
Feb 24, 2011GE Healthcare, LLC
7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa Openspeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support
Terminated
LNHK032795
Feb 24, 2011GE Healthcare, LLC
6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T) Signa Excite, 12x (K041476 Signa Excite 1.5T and 3.0T) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support h
Terminated
LNHK041476
Feb 24, 2011GE Healthcare, LLC
5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems) Signa HDxt (K052293 Signa HDx and HDxt MR Systems ) The GE Signa HD
Terminated
LNHK052293
Feb 24, 2011GE Healthcare, LLC
4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short
Terminated
LNHK052978
Feb 24, 2011GE Healthcare, LLC
3) Signa Advantage (K911959 Signa Advantage MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or
Terminated
LNHK911959
Feb 24, 2011GE Healthcare, LLC
2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and
Terminated
LNHK942604
Feb 24, 2011GE Healthcare, LLC
1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of th
Terminated
LNHK962061
Feb 23, 2011Siemens Medical Solutions USA, Inc
MAGNETOM Verio Nuclear magnetic resonance imaging
Terminated
LNHK072237
Feb 18, 2011GE Healthcare, LLC
GE Healthcare, Optima MR450w 1.5T MR systems The GE Signa MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Terminated
LNHK091536
Feb 18, 2011GE Healthcare, LLC
GE Healthcare Discovery MR450 1.5T, The Discovery MR450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicat
Terminated
LNHNone listed
Feb 18, 2011GE Healthcare, LLC
GE Healthcare Discovery MR750 3.0T The GE Signa MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Si
Terminated
LNHK081028
Dec 21, 2010Philips Medical Systems North America Co. Phillips
Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. Consists of diagnostic devices that produce cross sectional images, spectroscopy images and/or spectra in any orie
Terminated
LNHK031815
K041602
Nov 26, 2010Philips Medical Systems North America Co. Phillips
The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and Intera 1.5T MR systems". The Identification of the Synergy Flex-M/ Shoulder Coil 1.5T can be found on the dr
Terminated
LNHK001796
K031815
Nov 24, 2010GE Healthcare, LLC
Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.
Terminated
LNHK013636
Nov 19, 2010GE Healthcare, LLC
Signa Ovation, 0.35T MR Systems (MFO 1-4). Indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the musculoskeletal, vascular, cardiac, and
Terminated
LNHK002611
K033504
Nov 19, 2010GE Healthcare, LLC
Signa OpenSpeed, 0.7T MR Systems (HFO3-5).
Terminated
LNHK032795
Sep 17, 2010Philips Medical Systems North America Co. Phillips
Panorama 0.6T MRI Nuclear Magnetic Resonance Imaging System, Philips Panorama 0.6T Open MRI system, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143
Terminated
LNHK013858
Sep 17, 2010Philips Medical Systems North America Co. Phillips
Infinion is Nuclear Magnetic Resonance Imaging. Philips Infinion 1.5T System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A..
Terminated
LNHK003853
K011296
Sep 17, 2010Philips Medical Systems North America Co. Phillips
Polaris, Nuclear Magnetic Resonance Imaging System, Magnet Subsystem, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".
Terminated
LNHK003853
K011296
Sep 17, 2010Philips Medical Systems North America Co. Phillips
Eclipse, Nuclear Magnetic Resonance Imaging system, Magnet Subsystem, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".
Terminated
LNHK964626
Sep 17, 2010Philips Medical Systems North America Co. Phillips
Vista Nuclear Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A..
Terminated
LNHK931544
K964626
Sep 17, 2010Philips Medical Systems North America Co. Phillips
Edge Nuclear Magnetic Resonance Imaging System. "1.5T Edge High-Field Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".
Terminated
LNHK931544
K964626
Aug 19, 2010Odin Medical Technologies Ltd.
PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI device used to gather cranial images.
Terminated
LNHK032541
Feb 19, 2010Philips Medical Systems (Cleveland) Inc
MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications.
Terminated
LNHK003853
Jan 11, 2010GE Medical Systems, LLC
Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems
Terminated
LNHK041476
K052293 +3
Aug 25, 2009GE Medical Systems, LLC
Signa Openspeed 0.7T MR Systems, Model Numbers: Openspeed 3 (2138300-30), Openspeed 4 (2377062-5), Openspeed 5 (2377062-5, 2377062-30)
Terminated
LNHK032795
Aug 25, 2009GE Medical Systems, LLC
GE Healthcare Signa Ovation 0.35T, Model Numbers: Ovation 1-3 (2276937), Ovation 4 (2377062-2, 2377062-5, 2377062-8, or 5118172), and Ovation 5 (5148725). The 0.35T Signa Ovation with Excite Magnetic
Terminated
LNHK053009
Jun 30, 2009GE Medical Systems, LLC
GE Signa OpenSpeed 0.7T MR System. The 0.7T Signa OpenSpeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter sca
Terminated
LNHK032795
Jun 30, 2009GE Medical Systems, LLC
GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times.
Terminated
LNHK053009
Jan 27, 2009iCAD, Inc.
CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
Terminated
LNHNone listed
Jan 27, 2009iCAD, Inc.
CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response.
Terminated
LNHK031350
K050862
Sep 17, 2008GE Healthcare
GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or
Terminated
LNHK041476
Sep 17, 2008GE Healthcare
GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of
Terminated
LNHK052293
Sep 16, 2008GE Healthcare
GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System. Model Numbers 5107849, 5107849-2, M3000PT, and M3000PW . Indicated for use as a diagnostic imaging device to produce axial
Terminated
LNHK041476
Sep 16, 2008GE Healthcare
GE 1.5T and 3.0T Signa HDx MR System Model Numbers: 5127452, 2377062-61, and 2395001-2. Indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectr
Terminated
LNHK052293
Sep 11, 2008GE Healthcare
GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is indicated for use as a diagnostic imaging device to produce axial
Terminated
LNHK052293
Sep 2, 2008Resonance Technology Inc
Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System .
Terminated
LNHK994351

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.